Hot Pursuit     15-Nov-23
Gland Pharma gets tentative nod from US FDA for hypotension treatment drug
The generic injectable focused pharmaceutical company said that it has received tentative approval from the United States Food and Drug Administration (US FDA) for Angiotensin II Injection.

Angiotensin II is a medication that is used to treat hypotension resulting from septic shock or other distributive shock.

Gland Pharma believes that we are the only company with first to file for this product and may be eligible for 180 days of generic drug exclusivity.

The company will launch the product with its marketing partner on receipt of final approval.

The Angiotensin II Injection has US sales of approximately $38 million for twelve months ending in September 2023, according to IQVIA.

Gland Pharma is one of the largest and fastest growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions. The company also pioneered Heparin technology in India.

The company has reported 19.55% fall in consolidated net profit to Rs 194.08 crore in Q2 FY24 from Rs 241.24 crore in Q2 FY23. Revenue from operations jumped 31.50% to Rs 1,373.42 crore in Q2 FY24 as against Rs 1,044.40 crore recorded in Q2 FY23.

The scrip shed 0.95% to currently trade at Rs 1609.05 on the BSE.

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